MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The reason for call was patient stated they can't get the stimulation to go up at all.Patient stated they have 2 positions that they can set it on and they can make it go down but can't go up.Patient mentioned their back has given them all kinds of grief.Patient said when they try to increase the stimulation it just stands still and doesn't do anything.Patient service specialist asked when this started and patient said it hasn't been working right for quite a while and just noticed it about a week ago.Patient also mentioned they are in pain today.Patient had a return of pain.Patient was on group 1 at 4.9 and when they pressed the up button they saw settings not available.Patient confirmed this is not the first time they have seen this message.Agent reviewed meaning of the code.Agent advised to reset equipment and after reset confirmed blinking green light, agent advised to try and increase and pt again was seeing settings not available.Agent reviewed the ins needs to be checked.Pt states the manufacturer representative (rep) said to call and might be controller and agent reviewed.Patient plugged controller in to ac power supply without li battery and reported the screen came on.Patient put li battery back in and confirmed the green light was blinking on the controller.Patient unlocked controller and reported both batteries were at 100%.Patient tried to increase stim and reported settings not available.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Rep reported the lead was fractured, damaged, or broken.Patient had a loss of stimulation. the patient reported that they had noticed a change in therapy within the last six months.The patient reported that they were unable to use their current programming due to "unable to provide desired intensity" message.The patient was met and connectivity was established.It was discovered that the 0-7 lead was reading all electrodes red and not connected and the 8-15 lead was connected with the electrodes with in range.The patient denied any knowledge of a fall or trauma.Issue is ongoing.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 03-apr-2023, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(6), ubd: 20-apr-2022, udi#: (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: product type lead medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received from the consumer reported that when the patient had an appointment on (b)(6) the doctor told them the stimulation was only working on one side.Caller confirmed that stimulation was previously working on both sides.Caller stated that there was a rep there at the appointment.Caller said that the representative tried to adjust the stimulation and told the patient that it was not working and they couldn't get it to work.The caller was redirected to the patient's healthcare provider to further address the issue.The patient's relevant medical history included that they were in so much pain that they couldn't walk and couldn't stand, and now they could not walk at all.Caller noted more intense pain had begun around 6 months ago.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18977425
• MDR Text Key: 338572291
• Report Number: 3004209178-2024-07805
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2024
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Age: 84 YR
• Patient Sex: Male